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Cryomedical Sciences

This article was originally published in The Gray Sheet

Executive Summary

FDA will consider clearing the CMS urethral warming device for market via 510(k) if four conditions are met, the firm reports following a Feb. 2 meeting with FDA. The company must: submit "a new 510(k) designating the warmer as an 'accessory' to the already cleared AccuProbe or other cryosurgical devices for use in general urological procedures"; submit clinical data; inform existing CMS warmer investigational sites that the agency considers the study a "significant risk device study" requiring FDA clearance of the investigational protocol and plan; and submit an investigational device exemption application to FDA for continuing and further studies of the warmer. FDA recently had told the firm that the CMS urethral warmer would require a premarket approval application ("The Gray Sheet" Jan. 24, In Brief)
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